The descriptive term behavioral and psychological symptoms of dementia (BPSD) is used to cover a range of noncognitive disturbances including anxiety, depression, irritability, aggression, agitation, eating disorders, and inappropriate social or sexual behaviors. Behavioral and psychological symptoms of dementia are seen in about 90% of patients with dementia. We aimed to compare the efficacy and tolerability of risperidone, yokukansan, and fluvoxamine used for BPSD in elderly patients with dementia. Ninety inpatients with dementia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria were investigated in Sato Hospital, Koutokukai. We conducted an 8-week, rater-blinded, randomized trial, administering flexibly dosed risperidone, yokukansan, or fluvoxamine. Primary outcome measures were Neuropsychiatric Inventory in Nursing Home Version total score and its items. Secondary outcome measures were cognitive function measured by Mini-Mental State Examination and daily life function measured by Functional Independence Measure (FIM). Neurological adverse effects were measured by the Drug-Induced Extra-Pyramidal Symptoms Scale. At the end of the study, we analyzed 76 patients (92.7%). Mean Neuropsychiatric Inventory in Nursing Home Version total score decreased in all 3 drug groups, with no significant between-group differences. Mini-Mental State Examination and Functional Independence Measure scores did not change significantly. Drug-Induced Extra-Pyramidal Symptoms Scale scores did not change in the yokukansan and fluvoxamine groups, but increased significantly in the risperidone group. Risperidone, yokukansan, and fluvoxamine were equally effective in the treatment of BPSD in elderly patients. However, yokukansan or fluvoxamine for BPSD showed a more favorable profile in tolerability compared with risperidone. This trial is registered at UMIN Clinical Trials Registry (identifier: UMIN000006146).
From the *Department of Psychiatry and Behavioral Science, Graduate School of Medicine, Nippon Medical School, Bunkyo, Tokyo; †Sato Hospital, Koutokukai, Nanyo, Yamagata; and ‡Department of Cellular Signaling, Graduate School of Pharmaceutical Science, Tohoku University, Sendai, Miyagi, Japan.
Received May 15, 2012; accepted after revision November 19, 2012.
Reprints: Masatake Kurita, MD, PhD, Sato Hospital, Koutokukai, 948-1 Kunugizuka, Nanyo, Yamagata 999-2221, Japan (e-mail: firstname.lastname@example.org).
All authors participated in the design, execution, and analysis of this study and have seen and approved the final version.
This study was supported by funding from Koutokukai. This study was partly supported by a grant-in-aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of the Japanese Government and by a Health and Labour Sciences Research Grant for Research on Psychiatric and Neurological Diseases in Mental Health from the Ministry of Health, Labour and Welfare of the Japanese Government.